Trial Outcomes & Findings for Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration (NCT NCT02568189)

Results Overview

Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

112 participants

Primary outcome timeframe

Day 1

Results posted on

2024-06-13

Participant Flow

Study Halted when Misclassification of Study Outcome Discovered (Different IVC Collapse criteria on IVC Ultrasound)

112 participants and enrolled. 6 participants with inferior vena cava not visualized on ultrasound. These participants were not randomized.

Participant milestones

Participant milestones
Measure	Gastroenteritis 1 Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.
Overall Study STARTED	52	54
Overall Study COMPLETED	33	36
Overall Study NOT COMPLETED	19	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Sepsis 1 Sepsis patients receiving SonoSite Maxx Series Ultrasound System ultrasound prior to clinical orders including medication and fluid orders being placed by the treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Sepsis 2 Sepsis patients having SonoSite Maxx Series Ultrasound System ultrasound performed after clinical orders have been placed by the treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 1 Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.
Overall Study Protocol Violation	0	0	19	18

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sepsis 1 Sepsis patients receiving SonoSite Maxx Series Ultrasound System ultrasound prior to clinical orders including medication and fluid orders being placed by the treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Sepsis 2 Sepsis patients having SonoSite Maxx Series Ultrasound System ultrasound performed after clinical orders have been placed by the treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 1 n=52 Participants Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 n=54 Participants Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Total n=106 Participants Total of all reporting groups
Age, Continuous	—	—	6.93 years STANDARD_DEVIATION 6.10 • n=52 Participants	7.54 years STANDARD_DEVIATION 6.31 • n=54 Participants	7.2 years STANDARD_DEVIATION 6.2 • n=106 Participants
Sex: Female, Male Female	—	—	27 Participants n=52 Participants	26 Participants n=54 Participants	53 Participants n=106 Participants
Sex: Female, Male Male	—	—	25 Participants n=52 Participants	28 Participants n=54 Participants	53 Participants n=106 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Inferior Vena Cava Status IVC Collapse	—	—	39 Participants n=52 Participants	36 Participants n=54 Participants	75 Participants n=106 Participants
Inferior Vena Cava Status No IVC Collapse	—	—	11 Participants n=52 Participants	17 Participants n=54 Participants	28 Participants n=106 Participants
Inferior Vena Cava Status Not Visualized	—	—	2 Participants n=52 Participants	1 Participants n=54 Participants	3 Participants n=106 Participants

PRIMARY outcome

Timeframe: Day 1

Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)

Outcome measures

Outcome measures
Measure	Gastroenteritis 1 (Immediate) n=52 Participants Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 (Delayed) n=54 Participants Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 1 Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.
Type of Re-hydration Oral Rehydration	38 Participants	45 Participants	—	—
Type of Re-hydration IV Rehydration	14 Participants	9 Participants	—	—

PRIMARY outcome

Timeframe: Day 1

Population: Outcome measure for sepsis arms

For sepsis arm, Secured second vascular access point- type (Interosseous (IO), second Intravenous (IV), central venous (CV) access) within 15 min of physician evaluation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 minutes

Population: Outcome measure for sepsis arms

For sepsis arm, antibiotic given within 60 min

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 minutes

Population: Outcome measure for sepsis arms

For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Pediatric Intensive Care Unit (PICU), Floor, Discharge

Outcome measures

Outcome measures
Measure	Gastroenteritis 1 (Immediate) n=52 Participants Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 (Delayed) n=54 Participants Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 1 Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.
Disposition Status PICU	0 Participants	0 Participants	—	—
Disposition Status Floor	3 Participants	2 Participants	—	—
Disposition Status Discharge	49 Participants	52 Participants	—	—

SECONDARY outcome

Timeframe: Time between emergency department registration and disposition (admit, transfer or discharge)

Population: No participants enrolled in Sepsis arms

Outcome measures

Outcome measures
Measure	Gastroenteritis 1 (Immediate) Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 (Delayed) Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 1 n=52 Participants Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 n=54 Participants Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.
Length of ED Stay (From Sepsis Alert to Admission/Discharge Order Entry)	—	—	200 minutes Standard Deviation 121	177 minutes Standard Deviation 106

SECONDARY outcome

Timeframe: 48 hours

At greater than 48 hours post emergency department disposition

Outcome measures

Outcome measures
Measure	Gastroenteritis 1 (Immediate) n=52 Participants Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 (Delayed) n=54 Participants Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 1 Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.
Return ED Visit for Same Illness Within 48 Hours	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Outcome measure for sepsis arms

For sepsis arm, at time of emergency department or hospital discharge

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Assessed any time after 30 days from emergency department registration date.

Outcome measures

Outcome measures
Measure	Gastroenteritis 1 (Immediate) n=52 Participants Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 (Delayed) n=54 Participants Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 1 Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.	Gastroenteritis 2 Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician SonoSite Maxx Series Ultrasound System: Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.
30 Day Mortality	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Day 1

Population: Outcome measure for sepsis arms

For sepsis arm, during emergency department visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Population: Outcome measure for sepsis arms

For sepsis arm, during emergency department or hospital visit

Outcome measures

Outcome data not reported

Adverse Events

Sepsis 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sepsis 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gastroenteritis 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gastroenteritis 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James W Tsung MD, MPH

Icahn School of Medicine at Mount Sinai

Phone: 212 241 6272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place